Clinical Trial Diversity Rules

Researchers Scramble to Meet Clinical Trial Diversity Rules

Clinical trials are the long and complex process by which biopharmaceutical companies must prove the safety and efficacy of investigational new therapies to FDA before they can be considered for marketing approvals. The process usually takes about seven years from when a therapy enters clinical development phase 1 studies. Currently about 30,000 clinical trials are started each year.

About 85% of these trials will be delayed by at least 30 days or longer due to delays in patient enrollment. Of these clinical trials, about 30% will terminate because they will fail to achieve enrollment goals. From those clinical trials that do get past the enrollment hurdles, about 30% of the patients will drop out before the study completes.1

Historically and globally, over 80% of clinical trials were funded and executed in the US and EU2 resulting in massive inequities in access to people living outside of these relatively less densely populated regions of the world. This has resulted in a severe lack of diversity, equity, and inclusion of various underrepresented minority populations in clinical trials.

A typical clinical trial participant (~80%) is a white male adult from affluent backgrounds.3 People of certain age, gender, race, ethnicities, and geographic locations remain underrepresented in clinical trials. Children, women, LGBTQ+, African Americans, Hispanic, Asian-Indian, and rural populations remain disadvantaged and heavily underrepresented in clinical trials.

The pandemic driven decentralization of clinical trials is driving the adoption of a new generation of decentralized clinical trials software platforms that are delivering an increased ease of access to more diverse persons as they allow remote online access, home visiting nurses, and minimal travel and logistical burden.

Purpose built software solutions can help sponsors minimize the risk of enrollment delays and accelerate study startup with features such as intelligent automation of online patient screening and referral process, remote informed consent, remote patient education, omni channel patient engagement by email/SMS/telemedicine/video visits/, drag-drop patient recruitment workflows tailored to each study at the site or centralized at the Sponsor or CRO level, and alerts/reminders/ notifications.

Most clinical trials software systems are built for English speaking western population. This too had created barriers to deploying technology for recruitment and retention of diverse underrepresented populations. Systems with centralized monitoring of diversity parameters at site and study levels can help adjust the recruitment and retention strategies in real-time before its too late.

Decentralization of clinical trials does not automatically ensure DEIA (diversity, equity, inclusion, and access). A well-thought purpose developed platform with continuous feedback from customers and end-users is likely to ensure diversity of participants in decentralized clinical trials.

In April 2022, FDA issued guidance recommendations for sponsors developing medical products for developing and submitting a Racial and Ethnic Diversity Plan (REDP; Collection of Race and Ethnicity Data in Clinical Trials ( to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the US. Any product requiring an IND (investigational new drug) submission and/or for which clinical studies are intended to support marketing approvals for a standalone BLA (biologics licensing application), or an NDA (new drug application), or an IDE whether premarket notification (510(k)) or premarket approval (PMA) or a de novo classification request, or a humanitarian device exemption (HDE) application.

The FDA will now evaluate the race and ethnicity diversity plan as an important part of the sponsors development program. The REDP should be submitted as early as possible during the development process and before a pivotal trial can be approved. The REDP should include target disease epidemiology, evidence of prevalence/incidence of the disease among underrepresented racial and ethnic populations, study design and data collection plans, enrollment goals and specific plans for achieving enrollment and retention of diverse participants, and status of enrollment.

A clinical trial management software platform that is compliant with the FDA 21 CFR part 11 and other applicable guidelines, that includes modules for electronic data capture, remote decentralized clinical trial operations, patient recruitment and retention, that can also enable sponsors to support REDP recommendations and monitor the key performance indicators in real-time can enable better defensibility before, during, and after submission of their regulatory paperwork for the medicinal products.


  1. Decentralized Clinical Trials: Are We Ready to Make the Leap?” BioPharma Dive, 29 Jan. 2019,
  2. “Clinical Trials Have Far Too Little Racial and Ethnic Diversity.” Scientific American, Scientific American, 1 Sept. 2018,
  3. National Institute on Minority Health and Healthy Disparities, understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html)

Dr. Harsha Rajasimha is the Founder and CEO of Jeeva Trials. The personal experience of losing a child born with a rare disease and a brother with a chronic disease became the springboard for Dr. Harsha Rajasimha to apply his years of postdoctoral training at NIH and FDA to accelerating therapies for rare and common conditions. He knew that technology is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would guide their continuous learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to patients who need them by over 3x faster. The Virginia-based company’s modular software-as-a-service platform is fully scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials on any browser-enabled mobile device.